Adjustable socket system

ABSTRACT

An adjustable socket system is configured to accommodate a residual limb. The adjustable socket system has first and second opposed sides and includes a rigid first component arranged along the first side of the socket. An adjustable second component has a plurality of interconnected vertebrae elements connected to the first component and is arranged along the second side of the socket system. The adjustable prosthetic socket also has a base connector secured to the distal end area of the first component.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Patent Application61/405,766 filed Oct. 22, 2010, which is incorporated herein byreference.

FIELD OF THE INVENTION

The invention relates to the field of prosthetic devices, and moreparticularly to an adjustable socket for accommodating a residual limb.

BACKGROUND

A socket is commonly referred to as the portion of a prosthesis thatfits around and envelopes a residual limb or stump, and to whichprosthetic components, such as a foot, are attached. When providing asocket to an amputee, it is essential to properly fit the socket andalign various parts of the prosthesis to the amputee. Fitting andalignment of the socket are difficult tasks to perform, and requireextensive knowledge, training and skill on behalf of the prosthetist.

Typically, sockets for definitive prostheses are customized for aresidual limb of a particular wearer. According to one method, thesockets are formed over a model of the stump, such as one formed byplaster-of-paris, in a manner that is used to distribute forces betweenthe socket and the stump in a comfortable way to the amputee. In anothermethod, the socket may be obtained from computer aided design bymodeling the shape of the stump, and subsequently forming a model. Oncethe model is obtained in either of these methods, a socket is formedover the model by using fabric and liquid plastic resin to obtain adefinitive rigid socket customized to a particular limb.

Proper fitting of a socket to the stump is critical to the success ofthe prosthesis. The socket must fit closely to the stump to provide afirm connection and support, but must also be sufficiently loose toallow for circulation. In combination with proper fitting, the socketmust transfer loads from the residual limb to the ground in acomfortable manner.

Most prosthetic sockets are permanently formed to a customized shapethat is static, meaning that the socket does not account for shape andvolume fluctuations of the residual limb. When there are shape andvolume fluctuations, the fitting of the socket is impeded, with thesesockets causing discomfort, pain and soft tissue breakdown of the stump.In addition, conventional sockets tend to be bulky and cumbersome towear, and may be difficult to don making the residual limb uncomfortablewhen worn.

It is desirable to provide a simplified and compact prosthesis systemthat overcomes the drawbacks over known prosthesis systems.Particularly, it is advantageous to provide a socket system that isoff-the-shelf and capable of accommodating a variety of residual limbsizes. It is also desired that a socket system be adjustable to allowfor volume and shape fluctuations, and in effect, provide a dynamicsocket as opposed to the known static sockets. The adjustable socket canbetter adjust for pressure distribution, and maintain comfort to theamputee over a range of care and residual limb conditions.

SUMMARY

The challenges of known socket systems are addressed in accordance withembodiments of the invention providing an adjustable socket system. Theadjustable socket system is adapted to receive and fit a range ofheights and lengths of a residual limb, as well as accommodate volumeand shape fluctuations of a residual limb. From its versatility infitting and adjustment, the adjustable socket system can decrease pain,discomfort and soft tissue breakdown over known sockets that are staticin size and shape. Moreover, the adjustability of the socket provides anoff-the-shelf socket system that takes much of the guesswork out ofmaking a socket and provides an instant solution when urgency may berequired to provide an amputee with a socket.

In accordance with an embodiment of the invention, an adjustable socketsystem having first and second opposed sides includes a rigid firstcomponent having proximal and distal end areas. The first component isarranged along the first side of the socket. The adjustable socketsystem further includes an adjustable second component having proximaland distal end areas. The second component has a second plurality ofinterconnected vertebrae elements connected to the first component, andis arranged along the second side of the socket system. The adjustablesocket system includes a base connector secured to the distal end areaof the first component. The base connector may also be secured to thedistal end area of the second component.

A plurality of flexible and adjustable straps may connect the secondplurality of vertebrae to the first component. The first component mayalso include a first plurality of vertebrae with the first plurality ofvertebrae corresponding at least in part to the second plurality ofvertebrae. At least some of the first plurality of vertebrae may haveparallel or angled mating surfaces.

The individual vertebra of the second plurality of vertebrae may bepivotable relative to one another, and the second component may includea flexible spine upon which the second plurality of vertebrae issecured. Alternatively, the individual vertebra of the second pluralityof vertebrae may be pivotable and lockable in position relative to oneanother. The second component may be flexible relative to the firstcomponent which is rigid or semi-rigid.

The adjustable socket system may further include a proximal supporthaving first and second wings for providing medial-lateral support andis secured to he proximal end area of at least one of the first andsecond components.

The first plurality of vertebrae may have a first plurality of lateralflaps extending from the vertebrae. The second plurality of vertebraemay also have a second plurality of lateral flaps extending from thevertebrae. The lateral flaps may be flexible.

The first and second sides of the adjustable socket may respectivelycorrespond to posterior and anterior aspects of a residual limb.

In accordance with another embodiment of the invention, an adjustableprosthetic socket having first and second opposed sides includes a rigidfirst component having proximal and distal end areas. The firstcomponent has a first plurality of interconnected vertebrae elements andis arranged along the first side of the socket. The socket systemfurther includes an adjustable second component having proximal anddistal end areas. The second component has a second plurality ofinterconnected vertebrae elements connected to the first component andis arranged along the second side of the socket.

The socket further includes at least one tensioning element connectingthe first plurality of vertebrae and the second plurality of vertebrae.The at least one tensioning element is connected to at least onetensioner which is configured to adjust the tension of the at least onetensioning element. The socket may also include a base connector securedto the distal end area of the first component and the second componenthaving an adjustable width.

The individual vertebra of the second plurality of vertebrae may bepivotable relative to one another, and the first plurality of vertebraeand the second plurality of vertebrae may have a plurality of lateralflaps extending from the vertebrae.

The numerous advantages, features and functions of the variousembodiments of the adjustable socket system will become readily apparentand better understood in view of the following description andaccompanying drawings. The following description is not intended tolimit the scope of the adjustable socket system, but instead merelyprovides exemplary embodiments for ease of understanding.

BRIEF DESCRIPTION OF THE DRAWINGS

The inventive orthopedic device is described with reference to theaccompanying drawings which show preferred embodiments according to thedevice described herein. It will be noted that the device as disclosedin the accompanying drawings is illustrated by way of example only. Thevarious elements and combinations of elements described below andillustrated in the drawings can be arranged and organized differently toresult in embodiments which are still within the spirit and scope of thedevice described herein.

FIG. 1 is an elevational side view showing an embodiment of theadjustable socket system.

FIG. 2 is an elevational view showing the anterior side of the socketsystem according to FIG. 1.

FIG. 3 is an elevational view of the socket system of FIG. 1 showing a“bow” strap.

FIG. 4 is a schematic view of the socket system according to FIG. 1shown on a residual limb.

FIG. 5 is an anterior view of the anterior clamp element according tothe socket system of FIG. 1.

FIG. 6 is a perspective view of the anterior clamp element mounted on astrut according to the socket system of FIG. 1.

FIG. 7 is a perspective view of an underside of the distal end of thestrut base according to the socket system of FIG. 1.

FIG. 8 is a perspective view of topside of the distal end of the strutbase according to the socket system of FIG. 1.

FIG. 9 is an elevational view of another embodiment of a socket system.

FIG. 10 is a perspective view of a cup of the socket system of FIG. 9.

FIG. 11 is an elevational view of a distal component of the socketsystem of FIG. 9.

FIG. 12 is a perspective view of a circumferential vertebrae assembly ofthe socket system of FIG. 9.

FIG. 13 is a perspective view of circumferential sizes of thecircumferential vertebrae assembly of FIG. 12 for a residual limb.

FIG. 14 is a perspective view of an elongate vertebrae assembly of thesocket system of FIG. 9.

FIG. 15 shows a plurality of differently sized vertebra struts.

FIG. 16 shows a plurality of differently sized residual limb profiles.

FIG. 17 is a perspective view of condylar wings of the socket system ofFIG. 9.

FIG. 18 is a plan view of the socket system of FIG. 9.

FIG. 19 is a perspective view of an embodiment of the socket system.

FIG. 20 is a side view of the socket system of FIG. 19.

FIG. 21 is a perspective view of an anterior vertebra of the socketsystem of FIG. 19.

FIG. 22 is a perspective view of a posterior vertebra of the socketsystem of FIG. 19.

FIG. 23 is a perspective view of the distal base of the socket system ofFIG. 19.

FIG. 24 is a perspective view of the proximal support of the socketsystem of FIG. 19.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

A. Overview

A better understanding of different embodiments of the invention may behad from the following description read in conjunction with theaccompanying drawings in which like reference characters refer to likeelements.

While the disclosure is susceptible to various modifications andalternative constructions, certain illustrative embodiments are shown inthe drawings and will be described below in detail. It should beunderstood, however, that there is no intention to limit the disclosureto the specific embodiments disclosed, but on the contrary, theintention is to cover all modifications, alternative constructions,combinations, and equivalents falling within the spirit and scope of thedisclosure and defined by the appended claims.

It will be understood that, unless a term is expressly defined in thisdisclosure to possess a described meaning, there is no intent to limitthe meaning of such term, either expressly or indirectly, beyond itsplain or ordinary meaning.

Any element in a claim that does not explicitly state “means for”performing a specified function, or “step for” performing a specificfunction, is not to be interpreted as a “means” or “step” clause asspecified in 35 U.S.C. §112, paragraph 6.

The anatomical terms described herein are not intended to detract fromthe normal understanding of such terms as readily understood by one ofordinary skill in the art of prosthetics. For example, the term “distal”is used to denote the portion or end of a limb that is farthest from thecentral portion of the body. The term distal is the opposite of“proximal” which is used to denote that the end or portion of the limbis nearer to the central portion of the body.

Some of the components described herein share similarities to componentsin U.S. Pat. No. 7,488,349 and pending U.S. application Ser. No.12/275,459, incorporated herein by reference and belonging to theassignee of this disclosure.

B. Embodiments of the Adjustable Socket System

In accordance with an embodiment of the invention, FIG. 1 illustrates anadjustable socket system 10 that is adapted to receive and fit a rangeof heights and lengths of a residual limb, as well as accommodate volumeand shape fluctuations of a residual limb. From its versatility infitting and adjustment, the adjustable socket system can decrease pain,discomfort and soft tissue breakdown over known sockets that are staticin size and shape. Moreover, the adjustability of the socket provides anoff-the-shelf socket system that takes much of the guesswork out ofmaking a socket and provides an instant solution when urgency may berequired to provide an amputee with a socket.

The adjustable socket system 10 depicted in FIGS. 1-8 is configured toreceive a residual limb from a transtibial level amputation. It will beunderstood, however, that the adjustable socket system may be adapted toreceive a variety of different types of amputations, whether configuredfor the leg or arm.

Turning to the details of the embodiment of the socket system 10, thesocket system is shown as having a rigid strut device 12, asemi-flexible anterior clamp element 14 adjustably secured to the rigidstrut device 12, a semi-flexible posterior clamp element 16, and a strapsystem 24 connecting the strut device 14, the anterior clamp element 14and the posterior clamp element 16.

The strut device 12 is sufficiently rigid to resist deflection orbending, and stably holds the residual limb when it transfers weightbearing forces from the residual limb to the ground. The strap system 24functions as a weight bearing, flexible bag that contains the residuallimb and maintains it in connection to the strut device 12. The clampelements 14, 16, in combination with the strut device and the strapsystem, serve to clamp firmly the proximal portion of the residual limb,and distribute pressure exerted on the limb by the strap system.

As depicted in FIGS. 3 and 4, the socket system 10 is configured to beworn on the residual limb RL of a transtibial amputee. The strut device12 is mounted along the anterior side of the residual limb, and alongthe saggital plane of the leg. The strut device receives the distal endportion of the residual limb, and the anterior and posterior clampelements embrace the proximal portion of the residual limb, on anteriorand posterior sides, respectively, of the residual limb RL.Specifically, in this embodiment, the anterior and posterior clampelements generally correspond to the condylar regions of the residuallimb RL.

The strap system 24 runs along at least the anterior side of theresidual limb, such as with a bow strap 52 discussed more fully below,and along medial and lateral portions of the residual limb so as to forma bag about the leg. From this system of connections, the socket systemsecures the anterior, posterior, lateral and medial sides of theresidual limb.

1. First Embodiment of the Socket System

a. Strut Device

The strut device is connected to a flexible network of straps formingthe strap system, the semi-flexible clamp elements and a prostheticcomponent system, such as a foot, pylon and other components.

The strut device 12 has a strut base 18 forming a limb receiving portionor seat 26 adapted to receive a distal end portion of a residual limband an anterior opening 38 arranged for ventilating the rigid strut andaccommodating minor fluctuations of the volume of the residual limb.

A base connector 20 is secured to a bottom portion of the strut base 18,and is adapted to connect to prosthetic components, such as anartificial foot, and serve as a connection point for various straps ofthe strap system. The strut base 18 forms a sleeve 28 at an upper partthereof, and an adjustable strut 22 slidably engages the sleeve 28 andis lockable at a plurality of predefined height settings 30.

The limb seat 26 defines a plurality of slots 44 on the anterior sidearranged for receiving straps from the strap system, particularly thebow strap 52. The slots 44 allow for adjustment of the strap foranterior/posterior adjustment, as well as for medial and lateraladjustment.

The limb seat 26 also defines a plurality of fixation openings 46located on an outer side of the strut device 12, and arranged receivestrap end portions. The inner side of the limb seat 26 defines holes 50adapted to receive a fastener in order to secure the strap ends to thestrut device 12 at the distal end.

The base connector may be a coupling 48 in the form of a male/femalepyramid adapter allowing the strut device to connect to a variety ofcommercially available components, as would be understood by the skilledperson. In another variation, the base connector itself may be formed asa prosthetic foot, such that the socket system in combination with thefoot attached therewith forms a complete off-the-shelf prosthesis.

b. Strap System

The strut device and the clamp elements are linked to one another by thestrap system. The strap system comprises a plurality of straps that bearweight of the amputee and embrace the residual limb.

One of the straps forming the strap system is a bow strap 52, as shownin FIGS. 1 and 3. The bow strap 52 is an elongate vertical strapextending between the proximal and distal portions of the socket system.Specifically, the bow strap is mounted to the anterior clamp element 14,particularly at the sleeve 58, and is adjustably secured to the strutbase 18 at one of the slots 44. The bow strap 52 extends along the strutdevice, and according to a variation of the embodiment may extendagainst the strut device 12 along its length.

The bow strap is flexible so as to accommodate the residual limb yet itis under sufficient tension to provide stability and weight bearingfunctionality. The bow strap is preferably non-stretchable. Other strapsof the strapping system may be attached directly to the bow strap.

The fixation point of the bow strap to the strut base is achieved bypassing an end portion of the bow strap through one of the fixationslots 44 arranged in a series of rows extending between the anterior andposterior sides of the socket system. From the arrangement of the rows,the bow strap can be particularly arranged for anterior and posterioradjustment. The fixation slots 44 may also be configured sufficientlywide to allow for medial and lateral adjustment of the bow strap.

As noted, the limb seat 26 defines a plurality of fixation openings 46for receiving strap ends and holes 50 adapted to receive a fastener inorder to secure the strap ends to the strut device 12 at the distal end.By mounting the straps at the distal end of the strut device, the strapscan be placed in high tension, and can be adjusted for tension.

A variety of different strap systems may be used herein in combinationwith the strut device and the clamp elements. In one variation, thestrap system comprises a network of interconnected straps thatalternately secure to the anterior and posterior clamp elements as wellas to the bow strap. These straps may be tensioned by a single straptensioner or multiple strap tensioners 54. This combination of strapsfunctions similarly to a “Chinese finger trap” in that the network ofinterconnected straps are tightened with minimal adjustment, or mayautomatically tighten as an amputee places the residual limb into thesocket system.

According to another variation of the strap system, each strap may beadjusted individually by a strap tensioner. This type of strap systemcomprising individual straps allows for targeted adjustment of the strapsystem.

In yet another variation, the strap system may include a combination ofa network of straps and a plurality of straps that are individuallyadjusted. For example, the upper strap 40 connecting the anterior clampelement to the posterior clamp element may be individually adjusted,whereas the remainder of the straps may form part of a strap networkthat is adjusted by a single tensioner.

It will be understood that the strap system may include a combination ofstretchable and non-stretchable straps, as prescribed locations toaccommodate certain residual limb geometries or loading.

c. Clamp Elements

The anterior clamp element 14 secures to an upper end of the strut 22via a sleeve 58 formed by the anterior clamp element 14. The sleeve 58securely receives the strut 22, and forms a substantially rigid portionof the anterior clamp element 14. The anterior clamp element 14 ispreferably semi-flexible so that when straps, as in upper strap 40,connected to the anterior clamp element are tensioned, the anteriorclamp element 14 can flexibly yield in part to the anatomy of theresidual limb while withstanding loads exerted thereon by the amputee.Suitable padding 56 is provided against the anterior clamp element, aswould be available to the skilled person.

The semi-flexibility of the anterior clamp element is defined in part ashaving the property as being partially or somewhat flexible, such thatthe clamp element can bend about anatomy but still have sufficientrigidity and strength to withstand pressure exerted thereon by loadsfrom the residual limb and weight of the amputee.

The semi-flexibility of the anterior clamp element may be obtained inpart by the material used to form the clamp element as well as thegeometry of the clamp element. Specifically, the geometry of theanterior clamp element 14 includes upper and lower wings 32, 34 onopposed sides of the clamp element, and extending a distance from thestrut 22, and spaced apart in height by a gap 64 formed between theupper and lower wings 32, 34.

Each wing 32, 34 defines an arm 66 flexibly extending from the sleeve 58and includes a head 68 adapted to grasp part of the residual limb. Thehead is sufficiently configured to distribute pressure over the residuallimb when a strap connected thereto is tensioned. The arm 66 bendsrelative to the sleeve 58, and may have a thickness less than thethickness of the sleeve 58.

The wings 32, 34 of the anterior clamp element 14 are secured toposterior wings 36 of the posterior clamp element 16 by the strapsystem. Like the anterior wings 32, 34, the posterior wings 36 flexrelative to an elongate base portion 35 of the posterior clamp element.The posterior base portion 35 is more rigid than the posterior wings 36.

The combination of the semi-flexible anterior clamp element and thesemi-flexible posterior clamp element with the strap system permits thesocket system to adjust over a range of width of the residual limb.Stable and adjustable mediolateral support is obtained in directions 42toward the midline of the socket system by tensioning the strapsconnecting the anterior and posterior clamp elements.

The anterior clamp element 14 includes an adjustable anatomical section60 that can be adapted to accept a range of different anatomical shapesof the residual limb. An insert 62, such as a patella tendon bar or pad,may be secured to the anatomical section 60 so as to allow for loadingin an anatomically sensitive area. The insert is removable and differentinserts having different shapes, sizes, thicknesses, densities and etc.may be used to accommodate different sensitivity levels and geometriesof the residual limb.

2. Second Embodiment of the Socket System

FIG. 9 depicts another embodiment of the adjustable socket system 110.According to this embodiment, the socket system 110 includes a distalcomponent 112 adapted to rigidly secure to a residual limb, a proximalanterior component 114 secured to the distal component 112, and a distalposterior component 116 connected to the distal component 112 and theproximal anterior component 114.

The distal component 112 defines a strut base 118 having a baseconnector 120 defined at a distal end for securing to a prostheticcomponent system (not shown), such as a foot, pylon and other component.A telescoping strut 122 is slidably and lockingly secured to a proximalend of the strut base 118. The distal component 112 includes a cup 124adapted to secure to at least a distal portion of the residual limb, andhaving a valve 128. A ring 126 secures to the telescoping strut 122 andsupports the cup 124 with a retaining rim 130 formed by the cup 124.

The proximal anterior component 114 includes an upper wing 132 adaptedfor securing to a condylar region of a residual limb, and a lower wing134 adapted for securing to a paratibial region of a residual limb. Theproximal anterior component 114 includes a plurality of anteriorvertebra 136 arranged for adjustment relative to one another. Theproximal posterior component 116 also includes a plurality of posteriorvertebra 138 arranged for adjustment relative to one another.

The anterior vertebrae 136 are hingedly connected to the distalcomponent 112 at a hinge 140, and the posterior vertebrae 138 arehingedly connected to the ring 126 at a hinge 142. The upper and lowerwings 132, 134 are hingedly connected to the anterior vertebrae 136 at ahinge 144.

FIG. 10 illustrates the cup 124 as having a mounting band 146 configuredand dimensioned for the ring 126 to secure thereabout. The cup 124 alsodefines a profile adapted for securing to a general residual limb size.

The cup is preferably preformed and significantly simplifies the designof the socket assembly. It is understood that a third of the residuallimb is of a generally known shape and volume, and therefore the cup canaccommodate a variety different residual limb sizes. The cup is shapedso as to eliminate or minimize weight bearing at the distal end of theresidual limb.

The cup includes the valve 128 so as to be capable of providing suctionbetween the suspension liner and the cup. This allows for betterretention of the residual by the socket system.

The cup may be formed from a thin rigid plastic and generally matchesthe profile of a suspension liner. As is well understood in the art ofprosthetic devices, a suspension liner has a matrix or stabilizingumbrella that generally retains a shape of the distal end of thesuspension liner. The cup may be pre-formed and provided in a pluralityof sizes corresponding to standard suspension liner sizes.

In a variation, the cup can be formed to accommodate residual limb andshape sizes at the distal end of the residual limb. This variation ofthe cup is obtained by either making the cup semi-rigid, or making thecup flexible with additional supporting elements such as ribs, orproviding a strapping arrangement as discussed above.

FIG. 11 shows the distal component 112 as having the telescoping strut122 mounted on the strut base 118. The telescoping strut 122 is a sleeveextending over an upper end of the strut base 118, and is selectivelymounted at a plurality of height settings of the strut base 118 definedby openings 152 and secured by fasteners 154. The telescoping strutallows for adjustment to the height of the amputee therefore removingthe need for a prosthetic pylon.

A bracket 150 is formed on the ring 126 for connection to the proximalposterior component. The ring 126 is preferably formed from a rigidaluminum and is configured and dimensioned to securely fit to the cup124. In a variation of the ring, the ring may be formed to slightly flexso as to allow for shock absorption yet still provide a weight bearingstructure.

FIG. 12 depicts a circumferential vertebrae assembly defined by ananterior vertebra 136, a posterior vertebra 138, and a strap 156connecting the anterior and posterior vertebra 136, 138. The anteriorvertebra 136 defines a link 170, and a cover 158 extending over the link170 and forming an anterior abutment plate 160 for placement adjacent ananterior aspect of the residual limb. The straps are preferablyflexible, which allow for more forgiving retention of a residual limbover known rigid plastic or carbon fiber based sockets.

The posterior vertebra 138 similarly defines a link 186, and a cover 162extending over the link 186 and forming a posterior abutment plate 164for placement adjacent a posterior aspect of the residual limb. Theabutment plate 164 forms lateral arms 188 upon which a buckle 184 ismounted for receiving the straps 156. The buckle 184 may be a ratchetingtype or a clamping type known in the art of buckles for selectivelyadjusting and maintaining a length of the strap 156. The buckles allowfor quick and easy modification of fit for improved comfort.

FIG. 13 shows differently sized circumferences available for securing todifferently size residual limbs, as evidenced by a smaller circumference166 and a larger circumference 168, each obtained by the circumferentialvertebrae assembly.

In reference to FIGS. 14-16, the struts 172 connect the vertebra links170 to one another. Each of the links 170 is arranged to be fixed inangular position relative to other links by the fasteners 174. As shown,the links can be oriented forward or rearward 176A, 176B relative to oneanother. The ability to adjust each of the links allows for the socketsystem to accommodate differently shaped residual limbs, as exemplifiedin FIG. 16 by the residual limbs 178A, 178B, 178C.

As exemplified by FIG. 15, the struts 172A, 172B can be sizeddifferently relative to one another along the length of the proximalanterior component, or alternatively a clinician can select a singlelength strut among a plurality of differently sized links for use on thesocket system. The arrangement of the differently sized struts permitsadjustment in height of the length according to the length of theresidual limb.

While the anterior vertebrae assembly is depicted in FIG. 14, a similarconstruction is likewise obtained by the posterior vertebrae assembly.

Turning to FIGS. 17 and 18, the upper and lower wings 132, 134 are shownconnected to one another, wherein the upper wing 132 is arranged forcondylar support of the residual limb whereas the lower wing 134 isarranged for paratibial support. The wings are preferably semi-rigid orat least semi-rigid in certain regions and more flexible in otherregions. In a variation of the wings, the wings themselves may secure tostraps mounted on the proximal anterior component.

The upper and lower wings 132, 134 are connected at the hinges 180 andhinge 144 to the anterior vertebrae 136. The hinges 180 allow forlateral adjustment of the upper and lower wings 132, 134 relative to theanterior vertebrae 136. The lateral adjustment of the hinges 180 enablesadjustment of the shape and width of the wings by adjusting the distanceof the wings relative to the posterior vertebrae 138. A housing 182 isprovided over the hinges 180.

3. Third Embodiment of the Socket System

FIG. 19 shows another embodiment of the adjustable socket system 210.The socket system 210 includes a rigid spine 216 on the posterior side,a flexible spine 218 on the anterior side, a proximal support 224,lateral flaps 226 extending from either side of the spines 216, 218, anda distal base formed of a posterior distal base component 228 and ananterior distal base component 230. The socket system 210 may beadjusted to the shape and size of the residual limb by adjusting thelength of a cable 212 which is threaded around the socket using a dialtensioner 214. The circumference of the socket system 210 may also beadjusted by changing the positions of the distal base components 228,230. The height of the socket system 210 may further be modified toaccommodate the length of residual limb by adding or removing anteriorvertebrae 220 and posterior vertebrae 222 to and from the flexible spine218 and the rigid spine 216, respectively.

The embodiment described with respect to FIG. 19 uses a cable systemincluding a cable 212 as the tensioning element and dial tensioner 214to adjust the length of the cable 212. The dial tensioner 214 may beturned clockwise to decrease the length of the cable 212 and therebyincrease the overall tension of the socket system 210. To decrease theoverall tension of the socket system, the dial tensioner 214 may beturned counterclockwise to increase the length of the cable 212. Thecable system may be provided by Boa Technology Inc. and is alsodescribed in US 2009/0287128 which is incorporated herein by referenceand belongs to the assignee of this disclosure.

The cable system provides several advantages in the socket system 210.Since the cable system needs only one tensioner, it is simple for theuser to quickly adjust the tension in the entire socket system 210through the dial tensioner 214. With the dial tensioner 214, the tensionon individual areas of the socket system 210 does not have to beadjusted separately. Moreover, because the dial tensioner 214 hasrotational increments, the tension in the system may be incrementallyincreased or decreased to enable the socket system 210 to conform to thespecific user's residual limb.

Another advantage of the cable system is that the tension in the socketsystem 210 may be evenly distributed throughout the socket system 210which prevents pressure points from forming on different areas of theresidual limb. Pressure points on a residual limb are problematic inthat the pressure points cause irritation, pain, and discomfort to theresidual limb.

The cable system and the flexible spine 218 enable the user to adjustthe socket system 210 to suit the user's individual needs and specificresidual limb shape. In summary, the cable system on the adjustablesocket system 210 provides the user with a simple and fast way to adjustthe socket system 210 while increasing the comfort and improvingconformability of the socket system compared to conventional sockets.

While the embodiment described with respect to FIG. 19 uses a cablesystem including a cable 212 as the tensioning element and a dialtensioner 214 to adjust the length of the cable 212, the socket system210 may be adapted to be used with a variety of tensioning elementsincluding the strap systems of the previous embodiments, wires, laces,and commercially available buckle and strap type systems as would beunderstood by the skilled person. Further, the socket system 210 may beadapted for use with or without a prosthetic liner.

FIG. 20 is a side view of the socket system 210 without the cable systemshown in FIG. 19. The rigid spine 216 includes a plurality of posteriorvertebrae 222, a proximal end, and a distal end. The proximal endincludes a proximal end component 254, and the distal end is attached tothe posterior distal base component 228. The rigid spine 216 is arrangedto be angled relative to the longitudinal axis of the socket system 210,preferably having an angle between 0° to approximately 8° from thelongitudinal axis.

The flexible spine 218 includes a plurality of anterior vertebrae 220, aproximal end, and a distal end. The proximal end includes a proximalsupport 224 while the distal end is hingedly attached to the anteriordistal base component 230.

The anterior vertebrae 220 and posterior vertebrae 222 are arranged tohave an equal number of vertebrae in each of the spines 216, 218 suchthat the anterior vertebrae 220 have a corresponding posterior vertebra222. Alternatively, the spines 216, 218 may have an unequal number ofvertebrae.

As shown in FIGS. 19 and 20, each of the anterior vertebrae 220 andposterior vertebrae 222 has flaps 226 extending laterally on each sideof the vertebrae 220, 222. The lateral flaps 226 have a length such thatwhen the socket system 210 is worn on the residual limb, the anteriorflaps at least partially overlap the corresponding posterior flaps.

In reference to FIG. 21, a single anterior vertebra 220 is shown. Theanterior vertebra 220 in combination with the lateral flaps 226 hasoverall a circular shape which allows the anterior side of the socketsystem 210 to conform around the residual limb. The proximal hingeconnector 240 of the anterior vertebra 220 is connected to the distalhinge connector 242 of a second anterior vertebra 220 with a hinge pin.The hinge pin is configured to enable the proximal hinge connector 240and the distal hinge connector 242 to pivot about the hinge pin. Using aplurality of hingedly connected anterior vertebrae 220, a flexible spine218 is formed which conforms to the specific shape of the residual limb.While the hinge shown in this embodiment uses a hinge pin, a variety ofdifferent types of hinge joints may be used as would be understood bythe skilled person.

FIG. 22 illustrates a single posterior vertebra 222. A plurality ofposterior vertebrae 222 forms the rigid spine 216. Each posteriorvertebra 222 includes a pair of proximal posts 244 that engagescorresponding distal recesses of a second posterior vertebra 222 locatedon either side of the distal post 246. On the distal side of theposterior vertebra 222, the hollow distal post 246 protrudes towards thedistal end of the rigid spine 216. The distal post 246 fits within alongitudinal opening 248 of another posterior vertebra 222. The distalpost 246 further includes an opening at the distal end to allow cablesor cables to pass longitudinally through the rigid spine 216. Since thedistal post 246 extends past the opening 238, the sides of the distalpost 246 are provided with corresponding openings 238 to allow the cable212 to pass through the posterior vertebra 222.

The lateral flaps 226 which extend from each side of the anterior andposterior vertebra 220, 222 are discussed with reference to FIGS. 19-22.The lateral flaps 226 may be formed with the vertebrae 220, 222 togetheras a single component. Alternatively, the lateral flaps 226 may bedetachable from the vertebrae 220, 222 and may be attached to thevertebrae 220 in a variety of ways including mechanical attachments oradhesives as would be understood by a skilled person. As shown in FIGS.21 and 22, the lateral flap 226 forms a continuous, smooth inner surfacewith the vertebra with which the lateral flap 226 is attached.

The lateral flaps 226 may be formed from a semi-rigid material such asplastic. It is highly desirable that the lateral flaps 226 be breathableto increase the comfort of the residual limb within the socket system210. In view of this desire, the lateral flaps 226 are provided withperforations 234 to allow circulation of air through the flaps andaround the residual limb.

The lateral flaps 226 may further be lined on the interior side withdifferent materials such as a textile material, polymeric material,medical grade foam or a combination thereof. Different types of liningmaterial may also be used on different flaps 226 to target the specificarea of the residual limb with which the flaps 226 will come intocontact. For example, the medical grade foam may be applied to a flap226 which supports the fibula head of a residual limb for addedcushioning.

FIG. 23 shows the distal base of the socket system 210 having twocomponents 228, 230. The posterior base component 228 has a recess 250configured to receive the anterior base component 230. The anterior basecomponent 230 slidably engages the posterior base component 228. Theanterior base component 230 may be locked into different positions withrespect to the posterior base component 228 resulting in differentcircumferences for the socket system 210.

The posterior base component 228 and the anterior base component 230have raised anterior and posterior sides as can be seen in FIG. 23 andsubstantially form a cup to receive the distal end of a residual limb.Since the posterior end of the rigid spine 216 is connected to theposterior base component 228, the posterior base component 228 likewisehas a pair of base posts 252 and a recess similar to the proximal posts244 and recess 250 of the posterior vertebra 222.

The anterior base component 230 hingedly connects to the distal end ofthe flexible spine 218 similar to how each anterior vertebra 220 isconnected to each other. The anterior base component 230 has a basespine connector 232 similar to the proximal hinge connector 240 of theanterior vertebra 220.

The posterior base component 228 is adapted to be attached to aprosthetic limb such as the pylon of a prosthetic limb or a prostheticfoot and is made from a substantially rigid material to support theweight placed on the prosthetic limb. The posterior base component 228and the anterior base component 230 may be made of plastic, for exampleABS plastic.

FIG. 24 depicts a proximal support 224 which is attached on the proximalend of the flexible spine 218. The proximal support 224 has a pair ofwings 256 extending on either side of the vertebra component of theproximal support 224. The wings 256 are arranged for condylar support ofthe residual limb. Similar to the anterior vertebra 220, the proximalsupport 224 has openings 236 through which the cable 212 is able to passand a distal hinge connector 242. The wings 256 may have a secondopening 258 for the cable 212 which is formed from a groove in the wings256 and a raised surface 260 under which the cable 212 passes. The wings256 are also provided with perforations 234 similar to the lateral flaps226. In addition to the perforations 234, the wings may be lined withmaterials similar to those used in lining the lateral flaps 226 foradded comfort and support.

While the embodiments have been described herein with respect tospecific tensioning elements, a variety of tensioning elements may beused with the socket system including cables, wires, straps, laces orany other device used to provide and maintain tension as would beunderstood by the skilled person.

4. Closing

From the features of the adjustable socket system described above, anadjustable socket system is provided that provides simple and quickadjustment to the volume and shape of the socket system, and hence to aresidual limb supported by the socket system. In short, the socketsystem departs from the conventional static socket type and insteadallows for adjustment in height, volume and shape, thus permittingadjustment to assure stable fitting of the socket. Further, the socketsystem accommodates a variety of differently sized residual limbs, andis not constrained to a particular amputee but can be used by a varietyof amputees.

While the foregoing embodiments have been described and shown, it isunderstood that alternatives and modifications of these embodiments,such as those suggested by others, may be made to fall within the scopeof the invention. Any of the principles described herein may be extendedto other types of prosthetic or orthopedic devices.

The invention claimed is:
 1. An adjustable prosthetic socket havinganterior and posterior sides and defining proximal and distal ends, theprosthetic socket configured to fit around and envelope a residual limb,comprising: a distal base adapted to support a distal end of a residuallimb and located at the distal end of the socket; an elongate rigidspine located on the posterior side and extending upwardly from thedistal base toward the proximal end; an elongate flexible spine locatedon the anterior side and extending upwardly from the distal base on anopposed side from the rigid spine and extending toward the proximal end;a plurality of lateral flaps generally extending laterally relative to aheight of the socket and from at least one of the rigid and flexiblespines, and forming a variable circumference to the socket between theproximal and distal ends, the circumference of the socket adapted toextend around the residual limb and increases in circumference from thedistal base to the proximal end of the socket; wherein the flexiblespine includes first and second anterior vertebrae hingedly connected toone another and extending upwardly in generally a same orientation toform at least in part the elongate flexible spine.
 2. The adjustableprosthetic socket of claim 1, further comprising a cable systemconnecting the rigid spine to the flexible spine.
 3. The adjustableprosthetic socket of claim 2, wherein the cable system defines a cablealternatively extending from the rigid spine to the flexible spine alongthe length of the rigid and flexible spines.
 4. The adjustableprosthetic socket of claim 2, wherein the cable system extends over thelateral flaps along an exterior side of the prosthetic socket.
 5. Theadjustable prosthetic socket of claim 2, wherein the cable systemincludes a dial tensioner connected to the rigid spine and a cableextending over the plurality of flaps and connecting to the rigid andflexible spines, the dial tensioner engaging the cable and is arrangedto decrease the length of the cable to increase tension of the lateralflaps over a residual limb.
 6. The adjustable prosthetic socket of claim5, wherein the cable system is arranged to evenly distribute pressureover a residual limb.
 7. The adjustable prosthetic socket of claim 1,wherein the rigid spine includes a plurality of posterior vertebraeextending along the length of the rigid spine between the proximal anddistal ends.
 8. The adjustable prosthetic socket of claim 7, whereinsaid plurality posterior of vertebrae includes at least first and secondvertebrae interlockingly secured to one another and arranged to beimmovable relative to one another.
 9. The adjustable prosthetic socketof claim 8, wherein the first vertebra includes a distal post, and thesecond vertebra defines a longitudinal opening into which the distalpost extends to maintain the first and second vertebra in an immovablerelationship.
 10. The adjustable prosthetic socket of claim 7, whereineach of the plurality of posterior vertebrae carries at least one ofsaid plurality of lateral flaps.
 11. The adjustable prosthetic socket ofclaim 1, wherein the first and second vertebrae defining proximal anddistal hinge elements, the distal hinge element of the first vertebrahingedly securing to the proximal hinge element of the second vertebra.12. The adjustable prosthetic socket of claim 11, further comprising ahinge pin connecting the distal hinge element of the first vertebra tothe proximal hinge element of the second vertebra.
 13. The adjustableprosthetic socket of claim 11, wherein each of the plurality of anteriorvertebrae carries at least one of said plurality of lateral flaps. 14.The adjustable prosthetic socket of claim 1, wherein the rigid spine isarranged to be maintained rigid between the proximal and distal ends,and the flexible spine is arranged to adjust to a shape of the residuallimb between the proximal and distal ends by at least the first andsecond vertebrae.
 15. The adjustable prosthetic socket of claim 14,wherein the flexible spine includes a plurality of hinge elementsbetween the proximal and distal ends.
 16. The adjustable prostheticsocket of claim 1, wherein each of the plurality of lateral flapsdefines a curvilinear profile and first and second segments extendingfrom opposed lateral sides of one of the rigid or flexible spines. 17.The adjustable prosthetic socket of claim 1, wherein each of theplurality of lateral flaps is formed from a semi-rigid material.
 18. Anadjustable prosthetic socket having anterior and posterior sides anddefining proximal and distal ends, the prosthetic socket configured tofit around and envelope a residual limb, comprising: a cup-shaped distalbase adapted to support a distal end of a residual limb and located atthe distal end of the socket, an anterior side of the distal baseextending upwardly; an elongate rigid spine located on the posteriorside and extending upwardly from the distal base toward the proximalend; an elongate flexible spine located on the anterior side andextending upwardly from the anterior side of the distal base on anopposed side from the rigid spine and extending toward the proximal end,the flexible spine comprising a plurality of hingedly connectedvertebrae located along a length of the flexible spine between theproximal and distal ends generally forming a linear profile from thedistal to proximal ends of the prosthetic socket; a plurality of lateralflaps extending laterally from the plurality of vertebrae of theflexible spine, and forming a circumference to the socket between theproximal and distal ends, the circumference of the socket adapted toextend around the residual limb, the circumference of the socketincreasing from the distal base to the proximal end of the socket. 19.An adjustable prosthetic socket having anterior and posterior sides anddefining proximal and distal ends, the prosthetic socket configured tofit around and envelope a residual limb, comprising: a cup-shaped distalbase adapted to support a distal end of a residual limb and located atthe distal end of the socket; an elongate rigid spine located on theposterior side and extending upwardly from the distal base toward theproximal end; an elongate flexible spine located on the anterior sideand extending upwardly from the distal base on an opposed side from therigid spine and extending toward the proximal end; a plurality ofsemi-rigid and curvilinear lateral flaps connected to at least one ofthe rigid and flexible spines, and forming a circumference to the socketbetween the proximal and distal ends, the circumference of the socketadapted to extend around the residual limb; a cable system including adial tensioner connected to at least one of the rigid and flexiblespines and a cable extending over the plurality of flaps and connectingto the rigid and flexible spines, the dial tensioner engaging the cableand is arranged to decrease the length of the cable to increase tensionof the lateral flaps by urging a reduction of the circumference of thesocket over a residual limb, the cable circumferentially alternatingbetween the rigid spine and the flexible spine through a series ofopenings formed through the rigid and flexible spines between theproximal and distal ends.